IgG Food Screen 88 ELISA Kit

Sample

serum and plasma (EDTA, Citrate, Heparin)

Species Reactivity

Human

Intended Use

Enzyme immunoassay for the simultaneous, quantitative measurement of food specific IgG antibodies against 88 allergens in human serum and plasma (EDTA, Citrate, Heparin).

Storage

Store in a dark and cool place at 2-8°C / 36-46°F. All reagents (exception: wash buffer) are ready-to-use and packaged in bottles. The expiration date is printed on labels placed on the test packaging box. The expiration date of the kit is valid for all kit components, even if expiry of single components is different! After expiry all test components have to be discarded. In-use shelf life: at least 40 days at 2-8°C, but not longer than the expiry date.

Precision

Inter-assay precision Five tests were performed by the same person (Accuracy intraperson I Accuracy intertest) with 3 allergens. The coefficient of variation is 5-9% in dependency of the allergens. Inter-person precision Three tests were performed by 4 persons in quadruplicates, mean values of the tests of the same person were used for comparison to each of the other persons. Total number of tests: 48 wells. The mean coefficient of variation is 13.0%. Inter-lot precision Production of 3 different lots. Comparison of the test results of tests from these 3 ELISA KIT lgG lots. The decimal classes of the test for each allergen were compared to each of the other lots. 100 % of all tests show results within the tolerance of 1 class.

Sensitivity

Analytical sensitivity: For all foods- 0.35 U/mL Relative sensitivity: 81 %

General Description

It is intended to use as a tool to support the diagnosis of patients presenting various clinical symptoms associated with food intolerances. Advantage of the test is a non-invasive, quantitative measurement of plasma or serum samples for several foodstuff or –mixes at once. It is to be carried out by laboratory qualified personnel experienced in the use of in vitro diagnostic methods only. Lucretius once said that one man’s food may be another man’s poison. Individuals with allergies and other types of food sensitivities react adversely to certain foods and food ingredients that others can consume with no problems. Many different types of reactions are involved in these individual adverse reactions. Adverse food reactions may include IgE and non-IgE-mediated primary immunological sensitivities, non immunological intolerances (such as an enzyme deficiency or reactions to certain chemicals), as well as secondary sensitivities. Adverse immune reactions to foods which are not IgE mediated are often called food “intolerances.” The absence of IgE does not make them any less real; instead, other immune mechanisms, such as IgG or IgG4 antibodies are involved. IgG or IgG4-mediated adverse reactions to food are characterized by less severe reactions, are much more common (affecting approx. 45 % of the population) and have delayed onset (2 to 72 hours) after ingestion of an offending substance. Avoiding ingestion of such food (exclusion or rotation diet) is the best treatment to decrease symptoms. There are several evidences for the involvement of IgG or IgG4 in food 'intolerances' e.g.: • Allergic reactions may occur independently of antigen-specific IgE. • Subsequent decrease of IgG when the offending food is removed from the diet. • Specific serum IgG has been reported in cases of celiac disease, dermatitis, or atopic eczema, as well as in diseases with increased intestinal permeability, and inflammatory bowel disease (IBD). This evidence leads to the recommendation that IgG or IgG4-specific testing should be considered in cases where the patient shows unclear and chronic disorders, and in cases where classical diagnostics show no evidence.